en iso 14971 2012

Kanwal Jit Singh

C 603 Mithras Park, Rahatani Road, Pimpale Saudagar, Pune, 411027, INDIA Phone: +91 20 4674 3310 / +91 98204 44331 Email: [email protected]

Bringing fresh insights to add economic value by asking the right questions

EN ISO 14971:2012 Content Deviation # 3 IS IT IN TUNE WITH EU

REGULATORY FRAMEWORK

Content Deviation # 3 reads as follows

Risk reduction "as far as possible" versus "as low as reasonably practicable":

a) Annex D.8 to ISO 14971, referred to in 3.4, contains the concept of reducing risks "as low as reasonably practicable" (ALARP concept). The ALARP concept contains an element of economic consideration.

b) However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular. Essential Requirements require

risks to be reduced "as far as possible" without there being room for economic considerations.

c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations

Section 2 of Annex 1 to MDD read as follows

2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking

account of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer must

apply the following principles in the following order:

eliminate or reduce risks as far as possible (inherently safe design and construction),

where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,

inform users of the residual risks due to any shortcomings of the protection measures adopted.

ASPECT 1: CD$# 3 not in tune with the EU Legislative Requirements.

The content deviation has interpreted that the as far as possible in the first

indent of Section 2 of Annex 1 implies the absence of economic

considerations.

This blog examines this premise with reference to the legal interpretations

available today of the EU Regulatory Framework. The version of the directive

Kanwal Jit Singh



that is being referred to in this blog is 1993L0042 EN 11.10.2007

005.001

1. On Page 3 of the directive the first recital originating on the page reads

as

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to

minimizing or reducing risk must be interpreted and applied in such a way as to take account of technology and practice

existing at the time of design and of technical and economical considerations compatible with a high level of protection of

health and safety;

2. This recital clearly states that the reduction in the risks must be

interpreted and applied in such a way to

a. Take into account Technology and practices existing at the time

of design of the device

b. Take into account Technical and Economical Considerations

compatible with a high level of protection and safety

3. Therefore there is a clear conflict between the text of the CD# 3 and

the text in the recital.

4. The legislative value of a recital has been defined by the Joint Practice

Guide: Guide of the European Parliament, the Council and the

Commission for persons involved in the drafting of legislation within

the Community Institutions.

a. In terms of Part 10 of the Guide

i. The purpose of the recitals is to set out concise reasons for

the chief provisions of the enacting terms, without

reproducing or paraphrasing them. They shall not contain

normative provisions or political exhortations.

ii. The recitals are the part of the act which contains the

statement of reasons for the act;

iii. They are placed between the citations and the enacting

terms.

iv. Regulations, directives and decisions must state the

reasons on which they are based.

Kanwal Jit Singh



v. The purpose is to enable any person concerned to ascertain

the circumstances in which the enacting institution

exercised its powers as regards the act in question.

vi. This would provide the parties to the dispute the

opportunity to defend their interests and to enable the

Community judicature to exercise its power of review.

vii. The text of the relevant part of the Guide is available at

http://goo.gl/iUZ5qV

5. Thus the removal of economic considerations from the risk

management process is not in tune with the legislative intent of the

directive.

ASPECT 2: JUDICIAL DECISION ON ALARP

Item 3 of CD# 3 prohibits the use of ALARP by NBs in the assessment of the

Risk Management undertaken by manufacturers.

In this context, attention of the standard formulators is drawn to the

decision of European Court of Justice in case no. C 127/05 [Commission vs.

UK] decided on June 14, 2007.

The matter under consideration before the court was

Commission of the European Communities seeks a declaration from the

Court that, by restricting the duty upon employers to ensure the safety and

health of workers in all aspects related to work to a duty to do this only so

far as is reasonably practicable', the United Kingdom of Great Britain and

Northern Ireland has failed to fulfil its obligations under Article 5(1) and (4)

of Council Directive 89/391/EEC of 12 June 1989 on the introduction of

measures to encourage improvements in the safety and health of workers

at work

The Commission pleaded that

'... the improvement of workers' safety, hygiene and health at work is an objective which should not be subordinated to purely economic considerations

The plea of the Commission was the same as that stated in the justification

for the removal of ALARP and economic considerations from the Risk

Management Process by the manufacturers and Notified Bodies.

Kanwal Jit Singh



The Court decided in declaring that the term SAFAIRP (so far as is

reasonably practicable) is in tune with the requirements of the Directive

89/331/EEC and dismissed the action desired by the Commission.

IN this context, it is pertinent to invite attention to Paragraphs 34 and 35 of

the Opinion given by the Advocate General Mengozzi delivered on January

18, 2007.

The Judgment and Opinion can be accessed at http://goo.gl/OiTk0w and

http://goo.gl/4nqzdb respectively.

CONCLUSION

I therefore urge the powers that be within the EU to recognize the issues in

the standard and take appropriate action to remove this from the Annexes

in the standard.

en iso 14971 2012

Documents